Diagnostic Accuracy of Using Colonoscope With Near Focus Capability in Detecting Residual Colorectal Neoplastic Tissue After Endoscopic Mucosal Resection (EMR): a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- Positive Recurrent Adenomas Using White Light Near Focus Imaging
研究概览
简要总结
The purpose of this study is to compare the accuracy of using different endoscopic imaging technique (white light, white light with near focus, narrow band imaging (NBI), NBI with near focus) for detection of residual neoplastic tissue at site of prior EMR
详细描述
Residual neoplasia after EMR is a common. Optimal surveillance protocols are not clearly defined. There is a need for better imaging modalities to evaluate for residual disease. Suspected residual tissue can be confirmed with repeat colonoscopy or can be empirically treated. However, this can lead to either frequent colonoscopy or overtreatment. This presents more cost and financial burden to the patient. With the introduction of newer colonoscopes that have near focus/zoom capability, it is important to assess whether the near focus technology offers better accuracy for detection of residual neoplastic tissue. With better accuracy to confidently rule out residual neoplasia using newer imaging modality, additional treatment or biopsy at the previous EMR may be avoided. Furthermore, the interval for surveillance colonoscopy can be lengthened.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Post-EMR follow up at 6-12 months
排除标准
- •Non-corrected coagulopathy
- •Pregnancy
- •Breast feeding
研究组 & 干预措施
Endoscopic scar assessment
Using endoscope with high definition white light, high definition white light with near focus, narrow band imagining, and narrow band imaging with near focus.
干预措施: Olympus CF190 Colonoscope High definition white light (Device)
Endoscopic scar assessment
Using endoscope with high definition white light, high definition white light with near focus, narrow band imagining, and narrow band imaging with near focus.
干预措施: Olympus CF190 Colonoscope White light with near focus (Device)
Endoscopic scar assessment
Using endoscope with high definition white light, high definition white light with near focus, narrow band imagining, and narrow band imaging with near focus.
干预措施: Olympus CF190 Colonoscope Narrow band imaging (Device)
Endoscopic scar assessment
Using endoscope with high definition white light, high definition white light with near focus, narrow band imagining, and narrow band imaging with near focus.
干预措施: Olympus CF190 Colonoscope Narrow band imaging with near focus (Device)
Endoscopic scar assessment
Using endoscope with high definition white light, high definition white light with near focus, narrow band imagining, and narrow band imaging with near focus.
干预措施: Biopsy (Procedure)
结局指标
主要结局
Positive Recurrent Adenomas Using White Light Near Focus Imaging
时间窗: approximately 6 to 12 months post endoscopic mucosal resection
The number of positive diagnoses using white light near focus optical imaging only.
Positive Recurrent Adenomas Using White Light Imaging
时间窗: approximately 6 to 12 months post endoscopic mucosal resection
The number of positive diagnoses using white light optical imaging only.
Positive Recurrent Adenomas Using White Light Imaging Confirmed by Histology
时间窗: approximately 6 to 12 months post endoscopic mucosal resection
The number of recurrent adenomas diagnosed positive with white light imaging confirmed by standard histopathology of biopsy.
Positive Recurrent Adenomas Using Narrow Band Imaging
时间窗: approximately 6 to 12 months post endoscopic mucosal resection
The number of positive diagnoses using narrow band optical imaging only.
Positive Recurrent Adenomas Using Narrow Band Imaging Confirmed by Histology
时间窗: approximately 6 to 12 months post endoscopic mucosal resection
The number of recurrent adenomas diagnosed positive with narrow band imaging confirmed by standard histopathology of biopsy.
Positive Recurrent Adenomas Using Narrow Band Imaging Near Focus Confirmed by Histology
时间窗: approximately 6 to 12 months post endoscopic mucosal resection
The number of recurrent adenomas diagnosed positive with narrow band imaging near focus confirmed by standard histopathology of biopsy.
Positive Recurrent Adenomas Using Biopsy
时间窗: approximately 6 to 12 months post endoscopic mucosal resection
The number of positive diagnoses determined by standard histopathology assessment of biopsy.
Positive Recurrent Adenomas Using White Light Near Focus Imaging Confirmed by Histology
时间窗: approximately 6 to 12 months post endoscopic mucosal resection
The number of recurrent adenomas diagnosed positive with white light imaging near focus confirmed by standard histopathology of biopsy.
Positive Recurrent Adenomas Using Narrow Band Imaging Near Focus
时间窗: approximately 6 to 12 months post endoscopic mucosal resection
The number of positive diagnoses using narrow band optical imaging near focus only.
次要结局
未报告次要终点
研究者
Michael Wallace
Consultant, Professor of Medicine
Mayo Clinic